inLight Medical LED Pads used with Polychromatic light technology system
FDA Recall Z-1943-2021 · Posted None
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Recalling FirmInlightened Partners LLC
Recall StatusTerminated
Product CodeILY
Date Initiated2019-06-04
Date Terminated2021-06-25
Product Quantity926
Reason for Recall
LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.
Firm Action
On 6/5/2019, Medical Device Recall Letters were emailed to customers. Customers were instructed to examine the connector on the cord attached to their pad and compare it to photos provided in the Medical Device Recall Letter. The connectors for recalled product contain a v-shaped notch. Customers in possession of a pad with the connector matching the photos were requested to complete an Acknowledgement and Receipt Form. Customers with questions were asked to call Customer Service at 1-800-455-4116.
Root Cause
Component change control
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of CA, TX, NC, ID, CO, VA, FL, VT, AK, DC, MA, IL, AZ, MN, IA, TN, WI, WA, OK, MI, OH, GA, NY, IN, PA, NV, NJ, AR, CO , LA, MT, OR, SD, ND, MD, UT, MO, KY, NM, KS, AS, NE, WY, PR, MS and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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